Job Description:

• Actively participate and lead cross-functional teams in the matrix. Take steps to obtain and understand other functional area perspectives.


• Communicate effectively with internal and external stakeholders. Provide training and support to Veeva users as needed. Assist in the creation and maintenance of work instructions, Quick Reference Guides (QRG’s) and other procedural documents on key Veeva processes.


• The RIM Specialist will be a subject matter expert in the Veeva Regulatory Information Management (RIM) system with a focus on submissions, correspondence, registrations and commitments for all products worldwide. Ensure RIM Inbox requests for correspondence, commitments and registrations are entered in the Veeva system to meet data quality standards in the timelines established. As a subject matter expert in Veeva reporting be able to create, modify and run reports, as needed. Perform any ad hoc data entry requests in Veeva as they arise.


• Partner with the Data Stewardship team and users worldwide to insure that data quality standards in Veeva are met and support the resolution of any issues that are identified, striving for continuous improvements. Drive data quality and user engagement by advising Customer Engagement Liaison’s (CEL’s) and functional area colleagues on their use of the system..


• Support and maintain SharePoint sites. Insure that the appropriate usernames are mapped to security groups in Veeva in a timely manner. Support the resolution of any issues that are identified.


• Provide support for internal audits, HA inspections and corrective action plans.

Working Practices:

• Develop knowledge of Client' products, development and business process and key therapeutic areas.


• Refined attention to detail and critical thinking capabilities. Follow specific and stringent standards and processes.


• Establishes and executes plans for managing workload within their assigned project(s) through efficient resource utilization and within designated timeframes. Effectively adjusts plans to deal with changes and obstacles.


• Manage personal assignments. Shares their expertise and knowledge through the teaching, coaching and mentoring of various colleagues. Embraces a healthy work environment with sensitivity to the balance between personal and professional life.


• Demonstrates flexibility to work simultaneously on multiple projects and meet ambitious timelines.


• Collaborate across cultural and organization boundaries to achieve business results.


• Thinks in a clear, decisive manner, remains calm under adverse conditions.


• Participates in personal development of self with supervisor by providing and asking for continuous and honest feedback.

Experience and Educational Requirements:

• Demonstrated experience and understanding of the procedures and decision-making process of the Health Authorities, as it relates to RIM.


• A BS in a relevant scientific or technical field and 4-8 years of pharmaceutical industry experience.


• Experienced with the drug development process. Solid regulatory knowledge and previous experience in the Regulatory Information Management area.

Clear knowledge and experience with electronic submission standards and requirements such as eCTD. Firm, detailed knowledge and experience with computer systems in an R&D environment. Expert with desktop applications (MS Excel), R&D systems and all integration points with RIM systems. Follows technology trends. Excellent command of English language, both written and oral. Good presentation skills.